Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Glaucoma Filtering Surgery

Phase 4

Completed

• Conditions: Glaucoma
• Interventions: Device: Use of ologen Collagen Matrix in trabeculectomy (ologen); Drug: Use of Mitomycin-C (MMC) in trabeculectomy

• Registration Number: NCT01440751
• Lead Sponsor: Aeon Astron Europe B.V.

Brief Summary

The objective of this prospective randomised study is to compare the efficacy and safety of ologen CM (Collagen matrix) and Mitomycin-C (MMC) as adjuncts to filtration surgery in uncontrolled treated glaucoma cases, the efficacy being the primary objective and the safety being the secondary.

Detailed Description

"ologen ® CM" is a biodegradable collagen matrix. To prevent episcleral fibrosis and subconjunctival scarring thay may result in the surgical failure in trabeculectomy, its sporous matrix modulates the migrations and proliferations of fibroblasts to create a vascular and long-lasting bleb without the adverse effects, such as avascular thin bleb wall, bleb leak, hypotony, and inflammations, potentially caused by the regeneration suppression effects upon the use of cytotoxic agents as anti-fibrotic agents, such as MMC (Mitomycin-C)in the study.

Results of ologen CM studies have been published at conferences and published in peer-reviewed journals; ologen CM is approved in Europe as an aid for tissue repair, and by the FDA in the US as an adjunct in wound management(K080868). In general, over 6,000 ologen CM have been implanted worldwide during the past two years with good results and excellent safety profile.

The clinical trial is a phase-IV post-marketing FDA approved device study designed as open-label, randomised, parallel, and comparative. 128 patients at 8 sites are anticipated to be recruited according to the enrollment criteria, while randomisation will be assigned by a sealed envelope system after the patient has signed consent. Trabeculectomy is performed thereafter with either MMC or ologen CM applications as described in the protocol with postoperative parameters to be measured and analysed with non-parametric tests(Chi-square, Fisher's exact, Wilcoxon, and Mann-Whitney tests) as well as Kaplan-Meier survival models.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-14
• Study First Submitted QC: 2011-09-23
• Study First Posted: 2011-09-27
• Primary Completion: 2013-12
• Study Completion: 2015-12
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-30
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• Age > 30 years (inclusive)
• Uncontrolled treated glaucoma requiring trabeculectomy
• Subject must be able and willing to cooperate with investigation plan
• Subject must be able and willing to complete postoperative follow-up requirements
• subject must be willing to sign informed consent form

Exclusion Criteria

• Known allergic reaction to MMC or porcine collagen
• Neovascular, uveitic, aphakic glaucoma, previous incisional glaucoma surgery
• Prior cataract unless clear corneal incision
• Previous conjunctival or strabismus surgery
• Participation in an investigational study during 30 days prior to trabeculectomy
• Ocular infection within 14 days prior to trabeculectomy
• Pregnant or breast-feeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ologen Collagen Matrix	Use of ologen Collagen Matrix in trabeculectomy (ologen)	When performing glaucoma surgery, a trabeculectomy, use ologen Collagen Matrix instead of MMC before closing the conjunctiva
Mitomycin-C (MMC)	Use of Mitomycin-C (MMC) in trabeculectomy	When performing glaucoma surgery, a trabeculectomy, use MMC as antifibrotic agent before closing the conjunctiva

Primary Outcome Measures

Name	Time	Method
Intraocular pressure(IOP) reduction	At postoperative up to 24 months.	"Complete success" is consider for IOP less than 21mmHg(inclusive) with no glaucoma medications and with more than 20% reduction(inclusive) from baseline IOP.; Definition of success rate is calculated in percentage by the number of complete success patients over the total sample size.; "Qualified success" that meets the postoperative IOP requirements with postoperative glaucoma medicaitons and "Failure" of meeting the IOP requirements are the other efficacy parameters.; In the specified time frame, patients will also visit for record at day 1, 7, 14, 30, 90, 180 days, 12, 18, and 24 months.

Secondary Outcome Measures

Name	Time	Method
Postoperative complications and appearances	At postoperative up to 24 months.	Inspections of hyphema, severe anterior chamber reaction, hypotony, supercholoidal hemorrhage, flat anterior chamber, endophthalmitis, choroidal detachment, wound or bleb leak.; Visual acuity, bleb appearance, and anterior chamber inflammation.

Trial Locations

Locations (8)

VoldVision-Holf Eye Clinic; 🇺🇸 Rogers, Arkansas, United States

New York Eye and Ear Infirmary; 🇺🇸 New York, New York, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Institue of Ophthalmology and Visual Science; 🇺🇸 Newark, New Jersey, United States

Wills Eye Institue; 🇺🇸 Philadelphia, Pennsylvania, United States

Glaucoma Associates of Texas; 🇺🇸 Dallas, Texas, United States

Glaucoma Associates of New York; 🇺🇸 New York, New York, United States

Dean McGee Eye Institue; 🇺🇸 Oklahoma City, Oklahoma, United States